FDA’s Non-Response Response to My New York Times Op-Ed on Gay Blood Ban

On May 21, along with my frequent co-author Eli Adashi, I published an op-ed in the New York Timesraising some questions about FDA’s proposed guidance recommending a ban on taking the blood on any man who has had sex with another man in the past year, or in other words imposing a one year celibacy requirement on gay men if they want to donate blood. This built on our critique last July in JAMA, wherein we argued that FDA’s then-lifetime ban on gay men and MSM donating blood was out of step with science and the practice of our peer countries, as well as potentially unconstitutional.

Thanks to our work, and a concerted effort by public health, medical, and gay rights groups, FDA has finally moved off of that prior policy and recognized that it was unjustified, and discriminatory.

Just to put this in context It took more than 30 years to convince FDA that it was problematic to ban blood donation for a lifetime any man who ever had sex with another man, even if both have repeatedly tested negative for HIV, while it imposed only a one year ban on people who had sex with individuals known to be HIV positive or a sex worker. FDA is appropriately a conservative agency, but on this issue of the lifetime ban its willingness to listen and reconsider has gone beyond conservatism to the point of lunacy. [By the way to be clear, I *love* FDA. I represented them while at the DOJ and have a new book coming out about FDA in the fall. You can think highly of an agency but think they have a bad track record on an issue. This is critique not hater-aide].

Well with that background, one should be not so quick to assume that a move to a one year ban — a de facto lifetime ban for any gay man who is sexually active, even one who is monogamously married with children — is the best policy. To put it bluntly, refusing to change a lifetime ban for such a long period makes me skeptical we should accept a “just trust us” line on their new restrictive policy.

The question we raised in our op-ed was whether FDA had adequately justified retaining a one year ban in light of the evidence from places like South Africa (with a much shorter time period ban), Italy (which does individualized risk assessment instead of stigmatizing all gay men as high risk for disease), etc.

“New Blood-Donor Policy, Same Gay Stigma,” by I. Glenn Cohen and Eli Y. Adashi (Op-Ed, May 21), asserts that the Food and Drug Administration has failed to explain why it is proposing to revise the indefinite deferral policy for men who have had sex with men to a one-year deferral. Our rationale has indeed been articulated in the recent draft guidance “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products,” open for public comment.”

Actually what we said was that the explanation they offered was not good enough or in the words of our article they fail to “adequately explain” their decision. As we put it :

“It would be one thing to defend the one-year ban after examining alternative policies. But the new F.D.A. recommendation does not explain why it did not adopt shorter bans like South Africa’s (six months), stating only that “sufficient data are not available to assess the effectiveness” of a shorter ban.Some countries have dropped the need for blanket bans altogether. Italy has adopted an “assess and test” approach in which all prospective blood donors — regardless of sexual orientation — undergo extensive physical and psychological testing and get an individualized risk assessment. The existing evidence shows no sign that Italy has seen an increase in infected blood in its supply.

The F.D.A. has not adequately explained why this model is not appropriate, saying only that it would be “very difficult to validate and implement in our current blood donor system due to resource constraints.” The F.D.A. should reconsider its approach, or at the very least explicitly explain why it has selected a one-year ban and not other, we believe better, policy options. It should examine evidence from other countries that have found that individualized risk assessment, combined with quarantining blood during the short period when H.I.V. cannot be detected, is a fairer and more effective way of regulating the blood supply — especially when combined with the F.D.A.’s current policy of testing every pint of blood.”

Next FDA says

“The F.D.A. is committed to maintaining the safety of the country’s blood supply in the setting of current H.I.V. epidemiology through testing and application of equitable blood donor deferral policies supported by scientific evidence. Donor deferrals are still required for H.I.V. because even the most sophisticated tests miss very recent infections.”

This is a non-sequitur. Everyone agrees that maintaining safe blood supply is important and that no testing process is perfect (FDA estimates 1 in 2 million risk of missing an infection). But that is just as true of blood from straight men and woman as gay men. If all you cared about was avoiding any risk, even a small one, at any cost, the old lifetime ban would be the superior policy. Indeed, why stop there. Why not ban ALL blood donors from EVER donating because we always have some small risk of avoiding an infection? Everyone agrees that this would be crazy. The question is not how to eliminate all risk, but how to determine what risk (however small) to accept in exchange for increasing the blood supply. As we note in our op-ed the one year ban excludes an estimated 300,000 pints of blood annually. Is that trade off worth it? FDA has not explained its analysis.

Moreover, and I think more importantly, FDA has not adequately explained why we can’t do what Italy, Spain, and others have successfully done, and move to individualized risk assessment. FDA has not explained why we can’t do what South Africa has done, move to a 6 month ban. FDA has not in its guidance really explained anything about its reasoning process, its cost-benefit analysis, etc, and that is what it owes the American public.

Finally FDA says

“Some of the most compelling scientific evidence supporting the F.D.A. recommendation for a change to a one-year deferral came from Australia, a country of about 24 million with H.I.V. epidemiology similar to that of the United States.”

Again a non-sequitur. No one disputes that the Australian data shows that a one-year deferral is safe. The question is not whether it is sufficient but whether it is necessary. Again we can find evidence from the USA that the old lifetime ban was safe. But FDA has now (belatedly) recognized that while sufficient it was not necessary. Is the one year ban necessary? FDA should critically examine countries that have adopted less draconian measures and explain to us why the data from those countries is not compelling. I would like to think that the American health care system is at least as good as that of Italy and Spain. So why can’t we adopt the system they have apparently successfully adopted of individualized risk assessment? FDA has not given us a reasoned answer.

The last thing I will say is a bit of an administrative law surprise. Our Op-Ed and the FDA response both came out during the notice and comment period for the guidance. I would have thought that the agency would not publicly want to state in the New York Times that (my characterization) “our notice and comment process is a sham, because we have made up our mind and we won’t be listening to dissenting voices and consider conflicting data.” But I remain hopeful they will nonetheless remain open to examining the data and reconsider their decision.

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I. Glenn Cohen is the James A. Attwood and Leslie Williams Professor of Law at Harvard Law School and current Faculty Director of the Petrie-Flom Center. A member of the inaugural cohort of Petrie-Flom Academic Fellows, Glenn was appointed to the Harvard Law School faculty in 2008. Glenn is one of the world's leading experts on the intersection of bioethics (sometimes also called "medical ethics") and the law, as well as health law. He also teaches civil procedure. From Seoul to Krakow to Vancouver, Glenn has spoken at legal, medical, and industry conferences around the world and his work has appeared in or been covered on PBS, NPR, ABC, CNN, MSNBC, Mother Jones, the New York Times, the New Republic, the Boston Globe, and several other media venues.
He was the youngest professor on the faculty at Harvard Law School (tenured or untenured) both when he joined the faculty in 2008 (at age 29) and when he was tenured as a full professor in 2013 (at age 34).